The invention is in the field of surgery and particularly in the field of intestinal surgical procedures concerning resection, anastomosis, colostomy, esophagostomy, and the like.
The technique of surgical colostomy as a temporary solution to various colonic disorders has become an accepted and standard procedure for temporarily resolving the problems where a section of diseased colon must be removed for reasons such as diverticulitis, cancerous obstruction, perforation, trauma, etc. The technique of surgical cervical esophagotomy and tube gastrotomy are also accepted temporary procedures designed to protect esophageal anastomoses.
The major problem with intestinal anastomoses, especially those of the colon and esophagus are anastomotic dehiscences which are associated with high morbidity and mortality.
In the colon, the incidence of anastomotic dehiscences range from 5 to 69%, and at the turn of the century, it was associated with 30 to 50% mortality rate. This led to the development of fecal diversion procedures, colostomy, and ileostomy.
Recently, this proximal fecal diversion is being questioned. It is felt that it does not guarantee against anastomotic leaks and does not improve the morbidity of colonic surgery. The construction and subsequent closure of a colostomy is associated with a high morbidity and mortality which ranges from 0.5 to 57%, and to 0 to 34% respectively.
The mortality rate from colonic anastomosis leakage rises in patients with diverticulitis and low colonic resections. The mortality rate for emergency resection of the colon in the clinical setting reaches as high as 28%. Experimentally a 24% mortality rate has been reported in resection of simulated diverticulitis.
Esophageal dehiscences are associated with even higher morbidity and mortality. The perioperative mortality following esophageal surgery ranges from 6 to 57%. When associated with anastomotic leakage, these figures escalate from 50% to 100%.
Because of high esophageal leak rates, many structures have been used to reinforce the esophageal anastomosis. These include lung, visceral pleural patch, omentum, peritoneum, pericardium, intercostal pedicle, and gastric fundus. All these techniques have one thing in common; they lie external to the esophageal anastomosis and act as patches without preventing the secretions or food from coming in contact with the anastomosis. For this reason they have not been consistently reliable both experimentally and clinically.
Anastomotic technique, shock, peritoneal sepsis, inadequate bowel preparation, malnutrition, coagulopathy, technical difficulty, diabetes, steroid dependence, uremic abscess, fistula, peritonitis, fecal soiling, poor blood supply, distal obstruction, absence of serosa, advanced age, and tension factors which may compromise the healing of an intestinal anastomosis. A combination of some of the above factors should lead to a staging of the management by means of a colostomy rather than a primary resection and anastomosis. Colonic loading is particularly dangerous as a cause of anastomotic dehiscences.
As noted above, because of the high incidence of intestinal anastomosis to leak, the salivary esophago-gastrointestinal secretion, food and fecal flow are diverted by proximal clostomy, cecostomy, ileostomy, or cervical esophagotomy.
An intestinal anastomosis becomes leak proof only after it is completely sealed. The gastrointestinal tract heals much more rapidly than the skin. The tensile strength of the intestine is acquired earlier because the strength of a newly formed collagen reaches that of the old collagen more rapidly. A 10-to-12-day anastomosis has a very strong tensile strength because it is rigid and under less tension. The normal intestine can be shown to burst before disruption of the anastomosis.
In studies on dogs in connection with the present invention, the esophageal and colonic anastomosis were subjected to maximal stress. All dogs were fed on the first postoperative day, all dogs had no bowel preparation and had a maximal colonic load. Where gross dehiscences of the esophagus and colon were created, and a graft was not used, these animals died. In those where the implantation of the temporary intraintestinal graft was performed, there were no deaths. The graft has successfully prevented the esophageal and colonic anastomosis from leaking. It guarantees that the anastomoses and all the created gross dehiscences would procede to complete healing before the graft passed naturally in two to three weeks time. The graft becomes the innermost lining of the intestine and as such act as a protective barrier between the secretions, food or feces, and the intestinal mucosa. The implantation of the intra-intestinal graft has been demonstrated to be a safe, uncomplicated procedure which completely protects an anastomosis even in the presence of gross dehiscence.
As a solution to the anastomotic leak rate and the considerable complication rate accompanying proximal colostomy or esophagostomy, the present invention provides an intraintestinal graft that diverts all the salivary esophago-gastointestinal secretion, food, and fecal flow from the proposed anastomotic site more safely and expeditiously than any other method and does so with one operation only. This tube then substitutes for a colostomy and esophagostomy and prevents leakage at the anastomosis. This invention is applicable for anastomoses of most intestinal and related human and animal fluid ducts where a complete diversion of fluids is needed.* FNT * See Exhibits A,B